Apply to Trial

Compensation: Varies

Number of Visits: 5

Duration: 3 weeks

20 Participants Needed

Virtual Reality Exposure for Vaginismus
(VIVID 2 Trial)

Overseen ByKira McNamee, BBA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Unprovoked vaginal pain, Vulvar skin condition, Imperforate hymen, Epilepsy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Virtual Reality Exposure for Vaginismus?

Research on similar treatments, like therapist-aided exposure, shows that exposure therapy can help women with lifelong vaginismus successfully have intercourse and reduce fear and negative beliefs about penetration. This suggests that Virtual Reality Exposure, which is a form of exposure therapy, might also be effective for treating vaginismus.¹ ² ³ ⁴ ⁵

How does virtual reality exposure treatment for vaginismus differ from other treatments?

Virtual reality exposure treatment for vaginismus is unique because it uses computer-generated environments to help patients face and reduce their anxiety in a controlled setting, unlike traditional methods that may involve direct physical exposure or hypnosis. This approach is potentially more efficient and cost-effective, offering an immersive experience that can be tailored to individual needs.¹ ² ⁵ ⁶ ⁷

What is the purpose of this trial?

Vaginismus is a sexual dysfunction characterized by involuntary tightening of the pelvic floor muscles, preventing vaginal intercourse. It is defined by an intense fear of vaginal penetration, leading to persistent difficulties with vaginal intercourse and gynaecological exams. Psychological factors play a significant role in vaginismus. If the pelvic floor muscle tightening represents a defensive reflex, then treatment using a gradual exposure to feared stimuli using virtual reality may lead to an extinction of the phobic response, and to amelioration of vaginismus. If effective, the use of virtual reality technology can directly improve clinical care offered to those suffering from vaginismus.

Research Team

Lori Brotto, PhD, RPsych

Principal Investigator

University of British Columbia

Eligibility Criteria

This trial is for individuals with a vagina, aged over 19, who have been diagnosed with vaginismus—a condition causing involuntary muscle tightness that interferes with vaginal penetration for more than six months. Participants must be fluent in English, have normal or corrected vision to use VR technology and can travel to Vancouver. This includes cisgender women, gender-diverse individuals, transwomen post-surgery, and transmen without bottom surgery.

Inclusion Criteria

The investigators will recruit individuals who have a vagina. They expect that most participants will identify as cisgender, where sex is female and gender is woman, while others may have a female sex but identify as a different gender (e.g., genderdiverse). Transwomen (i.e., birth assigned males but identify as woman) who have had gender-affirming surgery (and so have a vagina) are eligible, as are transmen (i.e., birth assigned females but identify as men) who have not had bottom surgery (so have a vagina).

Inclusion criteria: In addition to having a vagina, participants must have a diagnosis of vaginismus that requires self-reported involuntary tightness of the vaginal musculature that causes persistent interference with vaginal penetration lasting \>6 months; aged \>19 y, of any sexual orientation. Participants must be fluent in English (psychoeducational materials and questionnaires delivered in English), have normal or corrected-to-normal vision (to view the VR scenes during exposure), and be able to travel to Vancouver.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo virtual reality exposure therapy with psychoeducation over 3 weeks, involving 3 x 2-hour sessions

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for ease of vaginal insertion, insertion pain, and frequency of sexual activity at 3-week and 3-month intervals post-treatment

3 months

2 visits (in-person)

Treatment Details

Interventions

Virtual Reality Exposure

Trial Overview The study tests if virtual reality exposure therapy can help people overcome the fear of vaginal penetration associated with vaginismus. By gradually exposing participants to feared stimuli through VR technology, the trial aims to reduce the phobic response and improve sexual function.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Virtual reality exposure plus psychoeducationExperimental Treatment1 Intervention

The investigators designed the VRE protocol based on interviews from our proof-of-concept study. Participants will take part in 3 x 2-hour sessions over a 3-week period. Treatment will adhere to three key principles: (i) Exposure will be prolonged, such that participants will use a VR headset to view a sexual scene multiple times; (ii) Treatment will proceed gradually, with the sexual activities depicted moving from non-penetrative (low fear) to penetrative (high fear); and (iii) Exposures will be repeated, with participants re-watching the videos until their fear response has habituated (i.e., level of distress = 10-20/100). Prior to their first VRE session, participants will be given access to a website with descriptions and images of a variety of VR sexual videos, which will allow them to select an exposure film based on comfort with/attraction to the virtual actor.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

Virtual reality (VR) exposure therapy has shown promise as an effective and cost-efficient alternative to traditional exposure therapy for treating anxiety disorders, particularly in reducing fear of heights and fear of flying.

The initial controlled studies indicate that VR can successfully immerse participants in a virtual environment, which may enhance therapeutic outcomes for various anxiety-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy.Rothbaum, BO., Hodges, L., Kooper, R.[2012]